Safety and Dose-finding Study of DC-TAB in Healthy Subjects
NCT02442557 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2015-05-13
Summary
The purpose of this study is to determine safety and appropriate dose of DC-TAB for selective immune tolerance induction in humans.
Conditions
Interventions
- BIOLOGICAL
-
recombinant human alpha B-crystallin
intravenous injection
- OTHER
-
placebo comparator
intravenous injection
Sponsors & Collaborators
-
Delta Crystallon BV
lead INDUSTRY
Principal Investigators
-
Floris Höppener, PhD, MD · Syneos Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-12-31
- Primary Completion
- 2010-10-31
- Completion
- 2011-07-31
Countries
- Netherlands
Study Locations
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